{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T22:32:16Z","timestamp":1792794736106,"version":"4.5.0"},"reference-count":19,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T00:00:00Z","timestamp":1772150400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"mAbxience Research S.L."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Background\/Objectives: To assess the clinical similarity in terms of efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety, and immunogenicity between MB09 (denosumab biosimilar) and the reference product [RP, (Prolia\u00ae)] up to 18 months in women with postmenopausal osteoporosis (PMO). Methods: Women with PMO received three doses of 60 mg of MB09 or RP subcutaneously, every 6 months [two doses in the main treatment period and one dose in the transition period (TP)]. The primary efficacy endpoint was the percent change from baseline (%CfB) in lumbar spine bone mineral density (BMD). Secondary endpoints included other efficacy parameters and PD, PK, safety, and immunogenicity assessments. Results: A total of 555 subjects received MB09 (N = 278) or RP (N = 277). At month 12, %CfB in lumbar spine BMD was comparable between groups (MB09 versus Prolia) and met the predefined equivalence margins. Secondary efficacy endpoints\u2014%CfB in lumbar spine BMD at 6 months and %CfB in hip and femoral neck BMD at 6 and 12 months\u2014were similar between groups. PD marker (serum carboxy terminal cross linking telopeptide of type I collagen) was similarly suppressed in both groups, and the inhibition was maintained in the TP. PK results showed similar denosumab systemic exposure for MB09 and the RP. Both study treatments were well tolerated with similar safety profiles throughout the study period. The incidence of anti-denosumab antibodies was very low. Conclusions: MB09 demonstrated equivalent efficacy to the reference denosumab in women with PMO. All secondary efficacy endpoints, together with PD, PK, safety, and immunogenicity assessments, supported MB09 as a denosumab biosimilar (NCT05338086, EudraCT No. 2021-003609-24).<\/jats:p>","DOI":"10.3390\/pharmaceutics18030291","type":"journal-article","created":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T10:41:02Z","timestamp":1772188862000},"page":"291","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Phase III Study to Confirm Clinical Similarity of MB09, a Denosumab Biosimilar, and Prolia\u00ae in Postmenopausal Women with Osteoporosis (SIMBA Study)"],"prefix":"10.3390","volume":"18","author":[{"given":"Jerzy","family":"Supronik","sequence":"first","affiliation":[{"name":"Osteo Medic s.c. Artur Racewicz, Jerzy Supronik, 15-351 Bia\u0142ystok, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elene","family":"Giorgadze","sequence":"additional","affiliation":[{"name":"National Institute of Endocrinology, Tbilisi 0159, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9747-8817","authenticated-orcid":false,"given":"Tomasz","family":"Blicharski","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Rehabilitation, Lublin Medical University, 20-954 Lublin, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"S\u00e1nchez-Vidaurre","sequence":"additional","affiliation":[{"name":"Medical Department, mAbxience Research S.L., 28050 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2324-6575","authenticated-orcid":false,"given":"Luis","family":"P\u00e9rez-D\u00edaz","sequence":"additional","affiliation":[{"name":"Medical Department, mAbxience Research S.L., 28050 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Paravisini","sequence":"additional","affiliation":[{"name":"Medical Department, mAbxience Research S.L., 28050 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susana","family":"Mill\u00e1n","sequence":"additional","affiliation":[{"name":"Medical Department, mAbxience Research S.L., 28050 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1979","DOI":"10.1056\/NEJMcp2307353","article-title":"Postmenopausal Osteoporosis","volume":"389","author":"Walker","year":"2023","journal-title":"N. Engl. J. Med."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"973","DOI":"10.1097\/GME.0000000000001831","article-title":"Management of osteoporosis in postmenopausal women: The 2021 position statement of the North American Menopause Society","volume":"28","author":"Blake","year":"2021","journal-title":"Menopause"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1007\/s00198-018-4704-5","article-title":"European guidance for the diagnosis and management of osteoporosis in postmenopausal women","volume":"30","author":"Kanis","year":"2019","journal-title":"Osteoporos. Int."},{"key":"ref_4","unstructured":"(2026, January 20). Prolia\u2014Summary of Product Characteristics. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/prolia-epar-product-information_en.pdf."},{"key":"ref_5","unstructured":"(2026, February 20). Izamby\u2014Summary of Product Characteristics. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/izamby-epar-product-information_en.pdf."},{"key":"ref_6","unstructured":"(2026, February 20). Denbrayce\u2014Summary of Product Characteristics. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/denbrayce-epar-product-information_en.pdf."},{"key":"ref_7","unstructured":"(2026, January 20). Prolia\u2014Highlights of Prescribing Information, Available online: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2025\/125320s219lbl.pdf."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"e70013","DOI":"10.1111\/cts.70013","article-title":"MB09, a denosumab biosimilar candidate: Biosimilarity demonstration in a phase I study in healthy subjects","volume":"17","year":"2024","journal-title":"Clin. Transl. Sci."},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Kaminsky, G., Gladysz, I., Supronik, J., Garcia, F., Espigares, A., Rico, C., and Dominguez, J. (2024, January 9\u201311). MB09 (denosumab biosimilar) vs. reference denosumab in PMO Primary results, Abstract #1773270, Endocrine Practice 30 (2024) S80\u2013S101. Proceedings of the American Association of Clinical Endocrinology 2024 Annual Meeting, New Orleans, LA, USA.","DOI":"10.1016\/j.eprac.2024.03.327"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"2149","DOI":"10.1210\/jc.2007-2814","article-title":"Effects of denosumab on bone mineral density and bone turnover in postmenopausal women","volume":"93","author":"Bone","year":"2008","journal-title":"J. Clin. Endocrinol. Metab."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"756","DOI":"10.1056\/NEJMoa0809493","article-title":"Denosumab for prevention of fractures in postmenopausal women with osteoporosis","volume":"361","author":"Cummings","year":"2009","journal-title":"N. Engl. J. Med."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"821","DOI":"10.1056\/NEJMoa044459","article-title":"Denosumab in postmenopausal women with low bone mineral density","volume":"354","author":"McClung","year":"2006","journal-title":"N. Engl. J. Med."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"202","DOI":"10.1093\/jbmr\/zjae016","article-title":"Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: The ROSALIA study","volume":"39","author":"Jeka","year":"2024","journal-title":"J. Bone Miner. Res."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1919","DOI":"10.1007\/s00198-024-07161-x","article-title":"Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: A double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis","volume":"35","author":"Reginster","year":"2024","journal-title":"Osteoporos. Int."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"117371","DOI":"10.1016\/j.bone.2024.117371","article-title":"SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial","volume":"192","author":"Chung","year":"2025","journal-title":"Bone"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"e1951","DOI":"10.1210\/clinem\/dgae611","article-title":"Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12","volume":"110","author":"Langdahl","year":"2025","journal-title":"J. Clin. Endocrinol. Metab."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"632","DOI":"10.1002\/jbmr.3641","article-title":"Change in Bone Density and Reduction in Fracture Risk: A Meta-Regression of Published Trials","volume":"34","author":"Bouxsein","year":"2019","journal-title":"J. Bone Miner. Res."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1977","DOI":"10.1002\/jbmr.3837","article-title":"Reply to: Change in Bone Density and Reduction in Fracture Risk: A Meta-Regression of Published Trials","volume":"34","author":"Bouxsein","year":"2019","journal-title":"J. Bone Miner. Res."},{"key":"ref_19","unstructured":"FDA-CDER-CBER (2026, January 19). Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Available online: https:\/\/www.fda.gov\/media\/82647\/download."}],"container-title":["Pharmaceutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1999-4923\/18\/3\/291\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T10:47:35Z","timestamp":1772189255000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1999-4923\/18\/3\/291"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,27]]},"references-count":19,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2026,3]]}},"alternative-id":["pharmaceutics18030291"],"URL":"https:\/\/doi.org\/10.3390\/pharmaceutics18030291","relation":{},"ISSN":["1999-4923"],"issn-type":[{"value":"1999-4923","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,27]]}}}